1) CLINICAL DATA MANAGEMENT

 

As part of Clinical Data Management service, MasterInnoMinds offer a full suite of database design services for traditional paper-based and/or Electronica Data Capture (EDC) systems. In-house team of Clinical Database Programmers are well experienced in a variety of EDC platforms to design the database and also to validate the data with in the Database system. The main services we offer but not limited to are

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− CRF/eCRF design and development

− CRF Annotation & Review

− Database Build & Design

− Data validation specifications

− Query Management

− Edit checks Programming & Testing

− Data processing through double data entry

− Query Management

− Safety Data Management & Reconciliation

− Data Export/Transfer

− Real-time data viewing and reporting

− Creating Test Data for 100% SDTM Testing

 

2) CDISC IMPLEMENTATION

 

MasterInnoMinds offer support to implement major CDISC standards – SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model) and SEND (Standard for Exchange of Nonclinical Data).

 

SDTM Deliverables:
− Designs of the SDTM datasets
− RAW to SDTM Mapping Specification
− Annotated CRFs
− SAS programs performing the conversion
− SDTM datasets
− Validation documentation
− SDTM compliance report using Pinnacle 21 Validator
− Data exception report

 

ADaM Deliverables:
− ADaM Specification
− SAS programs generating ADaM datasets
− ADaM datasets
− Validation documentation

− ADaM compliance report using Pinnacle 21 Validator
− Data exception report

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SEND Deliverables:
− SEND Mapping Specification
− SAS programs generating SEND datasets
− SEND datasets
− Validation documentation
− Data exception report